STEP: Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial

Sponsor

Kaiser Permanente (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04679675

Collaborator

National Cancer Institute (NCI) (NIH), University of Washington (Other), University of Texas Southwestern Medical Center (Other)

32,623

Enrollment

Location

Arms

32.1

Anticipated Duration (Months)

1016.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Self-Testing options in the Era of Primary HPV screening for cervical cancer (STEP) trial will evaluate effectiveness of home-based HPV kits for improving cervical cancer screening uptake and its cost-effectiveness. The investigators will compare cervical cancer screening uptake within six months among women randomized to different outreach approaches based on prior screening behavior: A) Adherent and coming due: direct mail HPV kit vs. opt-in HPV kit vs. education; B) Overdue: direct mail HPV kit vs. education; C) Unknown: opt-in HPV kit vs. education.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Neoplasm Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Cervical Cancer Cervical Dysplasia Human Papilloma Virus HPV-Related Cervical Carcinoma HPV Infection HPV-Related Malignancy	Other: Usual Care Behavioral: Education Behavioral: Direct Mail Behavioral: Opt-in	N/A

Detailed Description

The scientific objective of the proposed research is to study whether an in-home programmatic HPV screening outreach strategy improves cervical cancer screening initiation and uptake. Identifying new, patient-centered options that motivate continued screening initiation and uptake is essential now and in the future.

In August 2018, the US Preventive Services Task Force released updated cervical cancer screening guidelines that include human papillomavirus (HPV) testing alone (ie, primary HPV screening) as a newly recommended strategy for women aged 30-65 years. With primary HPV screening, home-based screening is an emerging option, because HPV tests (unlike Pap tests) can be performed on clinician- or self-collected samples. Self-collected samples are as sensitive as clinician-collected samples in detecting HPV and mailing HPV self-sampling kits increases screening participation. As US healthcare systems prepare to implement primary HPV screening, they will need to consider a variety of strategies. To date, HPV self-sampling randomized clinical trials have included only overdue women; no study has evaluated uptake and acceptance of HPV self-sampling kits as an alternative to in-clinic screening in a screening-adherent population.

Based on our Home-based Options to Make cervical cancer screening Easy (HOME) trial (ClinicalTrials.gov, NCT02005510), most women will test negative (88%) and can continue routine screening; 11% will require in-clinic follow-up: 3% directly to colposcopy (HPV-16/18+ results) and 8% to Pap because of "HPV+ other" results or an unsatisfactory result (<1%). For home-based HPV screening strategies to be successful, ensuring high follow-up compliance in the minority of women who test positive is critical.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32623 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The investigators will test interventions separately by prior cervical cancer screening behavior: Screening Adherent, Overdue, and Unknown history. Interventions will differ by screening behavior. Previously Adherent: Previously screened for cervical cancer with a known due date within three months Overdue: Never screened for cervical cancer; or HPV and Pap co-test >5.25 years ago [or Pap alone >3.25 years ago]; or no past Pap and continuously enrolled at Kaiser Permanente Washington for ≥3.25 years. Unknown Prior Screening Behavior: Enrolled at Kaiser Permanente Washington for ≥6 months and <3.25 years, with no recorded cervical cancer screening history. Cohort randomization allocation will be assigned as follows to intervention arms: Previously Adherent (Usual Care, Education, Opt-in, and Direct Mail); Overdue (Usual Care, Education, and Direct Mail); and Unknown (Usual Care, Education, and Opt-in).The investigators will test interventions separately by prior cervical cancer screening behavior: Screening Adherent, Overdue, and Unknown history. Interventions will differ by screening behavior. Previously Adherent: Previously screened for cervical cancer with a known due date within three months Overdue: Never screened for cervical cancer; or HPV and Pap co-test >5.25 years ago [or Pap alone >3.25 years ago]; or no past Pap and continuously enrolled at Kaiser Permanente Washington for ≥3.25 years. Unknown Prior Screening Behavior: Enrolled at Kaiser Permanente Washington for ≥6 months and <3.25 years, with no recorded cervical cancer screening history. Cohort randomization allocation will be assigned as follows to intervention arms: Previously Adherent (Usual Care, Education, Opt-in, and Direct Mail); Overdue (Usual Care, Education, and Direct Mail); and Unknown (Usual Care, Education, and Opt-in).

Masking:

Single (Investigator)

Primary Purpose:

Health Services Research

Official Title:

Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer: the STEP Trial

Actual Study Start Date :

Nov 20, 2020

Actual Primary Completion Date :

Jul 29, 2022

Anticipated Study Completion Date :

Jul 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Usual Care	Other: Usual Care Subjects will receive Kaiser Permanente Washington standard of care.
Active Comparator: Education	Behavioral: Education Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening.
Active Comparator: Direct Mail	Behavioral: Direct Mail Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will also receive an insert describing the home-based cervical cancer screening option and that a kit will be sent within 1 week. An HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
Active Comparator: Opt-in	Behavioral: Opt-in Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will receive an Opt-in Insert describing the home-based cervical cancer screening option and how to request a kit. Individuals can request a kit by phone or through a webpage. Individuals who request a kit will receive the HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.

Outcome Measures

Primary Outcome Measures

Rate of completing cervical cancer screening uptake by outreach approach and prior screening behavior [Within 6 months of randomization]
Returning the home kit and attending the recommended in clinic follow-up (if applicable); or receiving in clinic screening).
Incremental cost-effectiveness ratio by outreach approach and prior screening behavior [Within 6 months of randomization]
Incremental cost-effectiveness ratio, which will be defined for each outreach approach within each screening behavior subgroup. Also, comparisons across screening behavior subgroups of usual care plus education to usual care.

Secondary Outcome Measures

Rate of initiating cervical cancer screening by outreach approach and prior screening behavior [Within 6 months of randomization]
Returning the home kit or receiving in clinic cervical cancer screening.
Time from randomization to screening initiation and uptake by outreach approach and prior screening behavior [Within 6 months of randomization]
Time from returning the home kit or receiving in clinic screening.
Proportion of intervention group women who complete recommended follow-up after a positive kit result by outreach approach and prior screening behavior [Within 18 months of randomization]
Per current guidelines, in-clinic Pap after other-HR HPV positive; or colposcopy after HPV 16/18+ HPV self-collection
Proportion of intervention group women who do not screen, return the home kit or receive in-clinic screening by outreach approach and prior screening behavior [Within 6 months of randomization]
Screening uptake outcome (no screen, home kit, or in-clinic) by outreach approach and by prior screening behavior
Qualitative information from focus groups on patient preferences by prior screening behavior [6-12 months following study invitation]
Through focus groups, the investigators will explore patient preference for, and satisfaction with, home HPV screening and barriers to follow-up of abnormal screening results.
Health system costs to implementing home testing by outreach approach and prior screening behavior [3-5 years (projected)]
Economic assessment of system-level financial consequences of adopting home-based HPV screening for cervical cancer. These analyses will evaluate the needed time to follow-up for the next cervical cancer screening to reduce gaps in cervical cancer screening HEDIS metrics, which also addresses program affordability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 64 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Currently enrolled at Kaiser Permanente Washington
Female sex
30 years to 64 years of age
An intact cervix
Has a primary care provider at Kaiser Permanente Washington

Exclusion Criteria:

Anyone flagged by the delivery system as being on a non-routine screening schedule
Previously randomized to the intervention arm of the HOME trial or invited to the PATH study (Participants from the PATH study and individuals randomized to the intervention arm in the HOME Study are excluded from STEP because their prior inclusion in a STEP-related research study could influence their screening uptake and affect the outcome of this trial.)
On "do not contact list" for research studies
Currently pregnant or had a pregnancy-related procedure within prior 3 months
Language interpreter needed